Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TITANIUM DYNA-LOK SPINAL SYSTEM

K-Number: K953635 · 1995-10-30

ApplicantSofamor Danek USA,Inc.
Decision Date1995-10-30
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

TITANIUM DYNA-LOK SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek USA,Inc.. It received FDA 510(k) clearance on 1995-10-30 under 510(k) number K953635. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the TITANIUM DYNA-LOK SPINAL SYSTEM?

TITANIUM DYNA-LOK SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-30. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K953635.

When did TITANIUM DYNA-LOK SPINAL SYSTEM receive FDA 510(k) clearance?

TITANIUM DYNA-LOK SPINAL SYSTEM received FDA 510(k) clearance on 1995-10-30, under 510(k) number K953635.

Who is the listed applicant for TITANIUM DYNA-LOK SPINAL SYSTEM?

The FDA 510(k) record lists Sofamor Danek USA,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TITANIUM DYNA-LOK SPINAL SYSTEM?

The FDA product code for TITANIUM DYNA-LOK SPINAL SYSTEM is MNH. This falls under the ENT category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sofamor Danek USA,Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K991031COLORADO II SPINAL SYSTEMK984360COLORADO II SPINAL SYSTEMK992928CD HORIZON SPINAL SYSTEMK991036DANEK PLATE AND SCREW SYSTEMK991198DYNA-LOK PLUS SPINAL SYSTEMK991364MODIFICATION TO TENOR SPINAL SYSTEM-PLATES

View all 41 devices →

Related Devices (Code: MNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑